BEUDAMED
    1,659 results · 73ms · Sources: EU EUDAMED, US FDA

    PLANMED SOPHIE NUANCE CLASSIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    Planmed Verity

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLANMED VERITY

    FDA 510(k)
    FDA Class 2 ·Radiology

    Planmed Clarity 2D, Planmed Clarify S

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLANMED SOPHIE & PLANNED SOPHIE CLASSIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLANMED CYTOGUIDE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Planmed Clarity

    FDA 510(k)
    FDA Class 2 ·Radiology

    MOBILE SOPHIE MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    Planmed Verity

    FDA 510(k)
    FDA Class 2 ·Radiology

    Planmed ClarityGuide

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Planmed Oy·1 device

    Planmed Clarity

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Planmed Oy·1 device

    Planmed Clarity

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·Planmed Oy·1 device

    Planmed Verity

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·Planmed Oy·1 device

    Planmed Oy

    Importer
    🇫🇮 Finland·1 Manufacturer

    FI23/0000004

    Certificate
    MDR QMS·Planmed Oy·SGS FIMKO OY

    FI15/07007

    Certificate
    MDD Annex II (excluding section 4)·Planmed Oy·SGS FIMKO OY·2 Basic UDI-DIs

    Otoplan

    FDA registration
    CASCINATION·1 product·🇨🇭 Switzerland

    OTOPLAN

    FDA registration
    CASCINATION·1 product·🇨🇭 Switzerland